NCT05002283

Brief Summary

A patient specific surgical guide for harvesting of free gingival graft from the palate

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

August 1, 2021

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the guide

    accuracy of the predefined graft dimensions relative to the required dimensions of the recipient site in millimetres

    One month

Study Arms (1)

Study group

EXPERIMENTAL

the patients undergo free gingival graft harvest from the palate using a patient specific guide

Other: patient specific guide

Interventions

harvesting palatal free gingival graft using the patient specific guide

Study group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with intraoral alveolar defect requiring soft tissue augmentation

You may not qualify if:

  • \- patients with systemic diseases interfering with surgical interventions
  • \- Poor oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Study Officials

  • Mohamed Shawky, MSc

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 1, 2021

First Posted

August 12, 2021

Study Start

August 1, 2020

Primary Completion

July 31, 2021

Study Completion

August 1, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

the IPD will be made available upon request from the author

Locations